OASIS Study Meets Primary Endpoint with 41.7% of Patients Treated with JETREA® achieving VMA resolution at Day 28 post injection (p<0.001)
24 month safety data in line with JETREA® approved label
Leuven, March 24, 2015 - ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces positive topline results from its OASIS study with JETREA® (ocriplasmin). The OASIS study is a randomized, sham controlled, double masked study that followed up patients for 24 months post injection. The study was designed to provide long term controlled efficacy and safety data for JETREA® in patients being treated for symptomatic vitreomacular adhesion (sVMA). The OASIS study is the first controlled study with JETREA® of its kind since the results of the pivotal Phase III program were announced in 2011. The study includes 24 month follow up data, the longest period patients have been studied post treatment with this novel medicine.
The key findings of the study were as follows:
- 41.7% of patients treated with JETREA® achieved VMA resolution at Day 28 post injection compared with only 6.2% of patients who received a sham injection (p<0.001); and
- The JETREA® safety profile in this 24 month follow up study was consistent with the drug's overall safety profile as known from the approved label. No new safety events were identified.
The OASIS data compare favorably with the results from the pivotal Phase III program with JETREA® where VMA resolution was seen in 26.5% of patients at Day 28 post injection. In the Phase III program 10.1% of patients treated with a placebo injection achieved VMA resolution (p<0.001).
The OASIS data show the importance of improved patient selection in generating higher rates of VMA resolution with JETREA®. Recent real world data have confirmed that access to more advanced diagnostic technology such as SD-OCT, has enabled retina physicians to improve patient selection. As a result they have been able to select patients with focal VMA and an absence of Epiretinal Membrane (ERM), two criteria which have been shown to lead to better treatment outcomes with JETREA®.
Further analysis of all of the OASIS data, which will be interpreted with the help of retina physicians, is ongoing. The results from these analyzes are planned to be shared with the retina community at a major scientific meeting in H2 2015 (AAO).
Dr Patrik De Haes, CEO of ThromboGenics said,"We are pleased to report these positive results from this randomized, controlled trial. To see 41.7% of the overall patient study group treated with JETREA® achieving VMA resolution at Day 28, is an excellent outcome given that some patients had ERM. These positive data, alongside the confirmed safety profile, clearly demonstrate that with better diagnostic tools and improved patient selection, a single injection of JETREA® represents a very compelling treatment option for an important group of patients with symptomatic VMA."
Dr Ron Danis M.D., Chairman of the OASIS study Data Monitoring Committee (safety) and Professor at the University of Wisconsin-Madison said, "I am pleased to report that the safety profile of JETREA® has been consistent during the whole course of the study. Moreover, based on the data we reviewed, no adverse events recorded during this prospective OASIS study appear to have an impact on the ultimate visual outcome."
Dr Peter Kaiser, Professor of Ophthalmology at the Cleveland Clinic, Lerner College of Medicine commenting on today's announcement, said, "it is very encouraging to see the results from this prospective, randomized, sham-controlled, long term study confirm the real-world clinical data which we have started to see being published by a number of US retina clinics in the last 12 months. By choosing the optimal patient, it is clear from OASIS and these studies that JETREA provides a highly attractive treatment option for selected patients with vitreomacular adhesion. I believe that these efficacy and safety findings gives additional confidence to use JETREA."
Dr. Pravin U. Dugel MD, Managing Partner Retinal Consultants of Arizona and Clinical Professor at the USC Eye Institute, Keck School of Medicine, University of Southern California, LA, comments, "I am very encouraged with the long term safety data from this study which is consistent with previous findings. I am confident that these data and further interpretation of the full detailed data set in close collaboration with the retina community will enable us to build further confidence in JETREA® as part of a new emerging standard of care for the treatment of symptomatic vitreomacular adhesion."
In the US, JETREA® is approved for the treatment of adults with symptomatic VMA.
If left untreated, symptomatic VMA generally leads to significant visual distortion, deterioration in visual acuity, or even central blindness.
With JETREA®, retina physicians have access to the first and only pharmacological treatment option for VMA, allowing them to intervene earlier and potentially stop the progression of this debilitating disease.
Ends
For further information please contact:
| ThromboGenics Wouter Piepers, Global Head of Corporate Communications & Investor Relations +32 16 75 13 10 / +32 478 33 56 32 wouter.piepers@thrombogenics.com | Citigate Dewe Rogerson David Dible/ Malcolm Robertson Tel: +44 20 7282 2867 malcolm.robertson@citigatedr.co.uk |
About JETREA® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin. In the US, JETREA® is indicated for the treatment of symptomatic VMA. In Europe, JETREA® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. JETREA® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
JETREA® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
JETREA's Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA was generally well tolerated with most adverse events being transient and mild in severity.
About ThromboGenics
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic and oncology medicines. The Company's lead product, JETREA® (ocriplasmin), has been approved by the US FDA for the treatment of symptomatic VMA and was launched in January 2013.
ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of JETREA® outside the United States.
ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.